NCT02094833已完成3 期
Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP~T Combined Vaccine at 2, 4, and 6 Months of Age Versus Sanofi Pasteur's DTaP IPV//PRP~T Combined Vaccine at 2, 4, and 6 Months of Age + Hep B Vaccine at 1 and 6 Months of Age, in South Korean Infants Primed With Hep B at Birth
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 16
- 主要终点
- Number of participants with anti-Tetanus antibody concentrations ≥ 0.1 International unit (IU)/mL
研究概览
简要总结
The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's DTaP-IPV//PRP~T combined vaccine (Pentaxim™) given at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of age in South Korean infants that received a birth dose of Hep B and born to mothers documented to be serum anti-HBs Ag negative.
Primary Objective
- To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus, poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens (pertussis toxoid [PT] and filamentous haemagglutinin [FHA]) of Group A versus Group B, one month after the third dose of combined vaccines.
Secondary Objectives:
- To further study the immunogenicity of the two vaccination schemes, before the first dose and one month after the last dose of vaccines.
- To study the safety after each and any dose of vaccines administered in the two vaccination schemes
详细描述
Study participants who received a first dose of recombinant Hep B vaccine at birth will receive either DTaP-IPV-Hep B-PRP~T combined vaccine at 2, 4, and 6 months of age + 3 doses of Hep B vaccine or Hep B vaccine (Euvax B®) at 1 and 6 months of age and DTaP IPV//PRP~T combined vaccine (Pentaxim™) at 2, 4, and 6 months of age, according to the official vaccination schedule for Hep B, DTaP, poliovirus, and Hib vaccinations in South Korea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 30 to 40 days on the day of the first study visit
- •Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
- •Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
- •Participant and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- •Born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available)
- •Have received one documented dose of Hep B vaccine at birth according to the national recommendations.
排除标准
- •Participation in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- •Receipt of any vaccine in the 4 weeks preceding any trial vaccination (except Bacille Calmette Guerin (BCG) vaccine) or planned receipt of any vaccine in the 8 days following any trial vaccination
- •Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine
- •Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial
- •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
- •Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity
- •History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection, confirmed either clinically, serologically, or microbiologically
- •Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
- •Known thrombocytopenia, as reported by the parent/legally acceptable representative
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- •In an emergency setting, or hospitalized involuntarily
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- •Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
- •History of seizures.
结局指标
主要结局
Number of participants with anti-Tetanus antibody concentrations ≥ 0.1 International unit (IU)/mL
时间窗: 1 month post third vaccination
Anti-Tetanus antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
Number of participants with ≥ 4 fold increase in anti-PT and anti-FHA antibody concentrations (EU/mL) from 1 month pre-dose 1 to 1 month post-dose 3
时间窗: I month post dose 3
Anti-PT and anti-FHA antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 International Units (IU)/mL
时间窗: 1 month post third vaccination
Anti-Diphtheria antibodies will be measured by a toxin neutralization test
次要结局
- Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 IU/mL and ≥ 0.1 IU/mL International Units (IU)/mL(Day 0 Pre-vaccination)
- Number of participants with anti-Hepatitis B antibody concentrations ≥ 10 mIU/mL international unit (IU)/mL(Day 0 Pre-vaccination)
- Number of participants reporting solicited injection site and solicited systemic reactions, unsolicited adverse events, and serious adverse events following vaccination with either DTaP-IPV-Hep B-PRP~T combined vaccine or Pentaxim™ and Euvax B® vaccine(Day 0 and up to Day 180 post-vaccination)
- Number of participants with anti Diphtheria antibody concentrations ≥ 0.1 IU/mL International Units (IU)/mL(1 month post third vaccination)
- Number of participants with response to vaccine Pertussis toxoid (PT) and Filamentous Haemagglutinin (FHA) antigens(1 month post third vaccination)
研究者
研究点 (16)
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